Position Responsibilities
- Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.
- Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.
- Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.
- Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.
- Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
- Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.
- Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.
- Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.
- Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections.
Candidate Requirements
- BS/MS degree in a scientific discipline.
- 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
- Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.
- Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
- Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
- Hands-on experience with systems such as Veeva Vault is preferred.
- Highly proactive, decisive, and capable of independently managing key initiatives.
Skills Required
- BS/MS degree in a scientific discipline
- 10-15 years of experience in the pharmaceutical/biotech industry
- 5+ years in leadership roles within Quality or related functions
- Deep understanding of GxP and Quality System requirements for pharmaceutical/biotech
- Experience designing and optimizing Quality Management Systems
- Experience with digital quality systems including eQMS
- Hands-on experience with Veeva Vault is preferred
What We Do
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/ For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
